Atlas FDA

HBI

28 FDA 510(k) clearances · Product code

73 daysmedian time to decision
190 days90th percentile
28clearances measured

FDA profile

Official device name
Illuminator, Fiberoptic, Surgical Field
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 1 · 1996: 5 · 1997: 4 · 1998: 1 · 2000: 2 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Light-Guide Cables (K223183)Olympus Winter & Ibe GmbH2023-01-13
OptiLux LED Illuminator (K163185)Isolux, LLC2016-11-21
KOGENT SPETZLER LIGHTED SUCTION TUBES (K141781)Katalyst Surgical, LLC2015-04-09
LIGHT GUIDE CABLE (K111342)Schott North America2011-11-25
1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (K052979)Isolux, LLC2005-10-31
ENDOSCOPIC FIBEROPTIC CABLE (K021931)Gulf Medical Fiberoptics2002-09-06
ENDOSCOPIC FIBEROPTIC CABLE (K991208)Isolux America1999-06-23
LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (K983277)Cuda Products Co.1998-12-16
LUMINOUS 150 FIBEROPTIC ILLUMINATOR (K933593)Progressive Dynamics, Inc.1993-10-28
S1500 XENON LIGHT SOURCE (K922837)Endomedix1992-11-03
NEXTEC FIBEROPTIC CABLES (K922462)Nextec Corp.1992-09-21
LUMINOUS 250 FIBEROPTIC ILLUMINATOR (K921866)Progressive Dynamics, Inc.1992-07-08
NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL (K920167)Nextec Corp.1992-03-23
STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR (K904616)Storz Instrument Co.1991-04-19
VLS 5300 300W XENON LIGHT SOURCE (K904681)Vistek Corp.1990-12-18
XENON LIGHT SOURCE (K904609)Medical Dynamics, Inc.1990-12-18
FIBERLUME (K901108)Burton1990-03-28
STORZ FIBEROPTIC ENDO-ILLUMINATORS (K896549)Storz Instrument Co.1990-02-15
RYAN-STYLE DIRECTED INFUSION MANIPULATOR (K890398)Advanced Surgical Products, Inc.1989-02-17
FIBEROPTIC WIRE PICK LIGHTPIPE (K883857)Advanced Surgical Products, Inc.1988-09-29
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE (K883858)Advanced Surgical Products, Inc.1988-09-29
FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE (K883856)Advanced Surgical Products, Inc.1988-09-29
VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS (K883201)Vital Metrics, Inc.1988-09-26
VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION (K882956)Vital Metrics, Inc.1988-08-03
STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE (K854587)Storz Instrument Co.1986-02-04
MINNESOTA SCIENTIFIC, INC. OMNI-BEAM (K853948)Minnesota Scientific, Inc.1985-10-16
FIBER OPTIC ADAPTERS#60-0893 (K810300)Aspen Laboratories, Inc.1981-02-27
FIBER OPTIC ADAPTERS#60-0891 (K810299)Aspen Laboratories, Inc.1981-02-27

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Every clearance here is in the API, with alerts when new ones post.